Protocol summary

Summary
The aim of the current double-blind, placebo controlled randomized clinical trial is to study the effects of Probiotic supplement containing Lactobacillus acidophilus, LA-5 and Bifidobacterium, BB12 on weight changes, glucose metabolism and inflammatory and oxidative stress indices in women with gestational diabetes mellitus. Sixty four volunteer pregnant women, singleton primigravida, with gestational diabetes mellitus diagnosis without the history of diabetes, hypoglycemic drug usage, chronic disease, smoking, alcohol consumption and Probiotic food products consumption in current two weeks will be included in the study and in case of need for insulin or other hypoglycemic drugs, they will be excluded. All the participants will be divided into experimental and control groups using random sampling method and they will receive one Probiotic or placebo capsule along with dietary advice for eight consecutive weeks, respectively. Ten milliliter blood drawn via venous puncture will be subjected for analysis of biochemical markers including glucose metabolism indices (serum glucose and insulin, HOMA-IR and QUICKI indices), inflammatory indices (highly sensitive C- reactive protein/hs-CRP, TNF-α and Interleukin-6) and oxidative stress indices (total antioxidant capacity/TAC, malondialdehyde/MDA, superoxide dismutase/SOD, glutathione reductase/GSH-R, glutathione peroxidase/GSH-Px and uric acid). Also weight changes will be determined by digital scale before and after intervention. The data will be entered in related software and analyzed by appropriate statistical methods to study the effect of the intervention on serum levels of the selected bio-markers and weight changes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405181597N3
Registration date: 2014-06-16, 1393/03/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-16, 1393/03/26
Registrant information
Name
Majid Hajifaraji
Name of organization / entity
National Nutrition & Food Technology Research Institute of IRAN (NNFTRI)
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0661
Email address
m39faraji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-05-29, 1393/03/08
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of Probiotics in comparison with placebo on glucose metabolism, weight changes and inflammatory and oxidative stress indices in women with gestational diabetes mellitus
Public title
Effect of Probiotics on diabetes mellitus arising in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: nulliparity; diagnosis of gestational diabetes mellitus between 24 weeks and 0 days and 28 weeks and 6 days of pregnancy with oral screening test; fasting blood glucose level between 92- 126 mg/dl; body mass index 18.5 and more; nulliparity; negative history of f diabetes mellitus before the current pregnancy; chronic diseases; Smoking and/or alcohol consumption; probiotic food products consumption through current 2 weeks; antibiotic usage through current month; acute GI condition through current month and glucocorticoid and immunosuppressor drugs usage Exclusion criteria: need for insulin or other hypoglycemic drugs; corticosteroids or immune-suppressants usage or acute GI condition during the study
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients will be randomly included in intervention and control groups through sequential matching based on pre-pregnancy body mass index (18.5 to 24.9, 25 to 29.9 and 30 and more kilograms per square meter) and fasting plasma glucose (92 to 104 and 105 and more milligrams per deciliter)

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
The International Branch of Shahid Beheshti University of Medical Sciences and Health Services
Street address
19, Shahid Abbasspour St., Vali-Asr Ave., Tehran, Iran
City
Tehran
Postal code
Approval date
2014-05-18, 1393/02/28
Ethics committee reference number
116.449

Health conditions studied

1

Description of health condition studied
Gestational Diabetes Mellitus
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy

Primary outcomes

1

Description
Fasting Blood Glucose
Timepoint
Before and after intervention
Method of measurement
Enzymatic

2

Description
Fasting Plasma Insulin
Timepoint
Before and after intervention
Method of measurement
Elisa

3

Description
Homeostatic Model Assessment/HOMA-IR
Timepoint
Before and after intervention
Method of measurement
Calculation

4

Description
Quantitative Insulin Sensitivity Check/QUICKI-index
Timepoint
Before and after intervention
Method of measurement
Calculation

Secondary outcomes

1

Description
Highly Sensitive-C Reactive Protein/hs-CRP
Timepoint
Before and after intervention
Method of measurement
Elisa

2

Description
Tumor Necrozing Factor Alpha/TNF-α
Timepoint
Before and after intervention
Method of measurement
Elisa

3

Description
Interleukine-6
Timepoint
Before and after intervention
Method of measurement
Elisa

4

Description
Toatal Antioxidant Capacity/TAC
Timepoint
Before and after intervention
Method of measurement
Elisa

5

Description
Malondialdehyde/MDA
Timepoint
Before and after intervention
Method of measurement
Enzymatic

6

Description
Glutathione Reductase/GSH-Red
Timepoint
Before and after intervention
Method of measurement
Elisa

7

Description
Superoxide Dismutase/SOD
Timepoint
Before and after intervention
Method of measurement
Elisa

8

Description
Glutathione Peroxidase/GSH-Px
Timepoint
Before and after intervention
Method of measurement
Enzymatic

9

Description
Uric Acid
Timepoint
Before and after intervention
Method of measurement
Enzymatic

10

Description
Weight
Timepoint
Before, 2 weeks, 4 weeks, 6 weeks and 8 weeks after intervention
Method of measurement
Digital scale

Intervention groups

1

Description
Control: in control group, 32 pregnant women after the entry qualifications, will take one tablet of placebo with the shape and color exactly similar to 4biocap for 8 weeks and variables will be analyzed before and after the intervention.
Category
Treatment - Drugs

2

Description
Intervention: in intervention group, 32 pregnant women after the entry qualifications will take one capsule of 4biocapⓇ containing 180 mg(>1 billion CFU) of a standardized, cream colored powder consisting of freeze-dried cultures of: Lactobacillus Acidophilus LA-5Ⓡ, Bifidobacterium, BB-12Ⓡ, Streptococcus Thermophilus, STY-31 and Lactobacillus Delbrueckii ssp. Bulgaricus, LBY-27, once a day for 8 weeks and variables will be analysed before and after the intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital-Tabriz University of Medical Sciences
Full name of responsible person
Dr.Fateme Abbasalizadeh
Street address
Alzahra Hospital, Artesh St., Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr.Hamid Soori
Street address
International Branch, 19, Shahid Abbspour St., Vali-Asr Ave., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Neda Dolatkhah
Position
MD., Ph.D student of Nutrition Sciences
Other areas of specialty/work
Street address
International Branch, 19, Shahid Abbaspour St., Vali-Asr Ave., Teharn, Iran
City
Tehran
Postal code
Phone
+98 218820902021
Fax
Email
neda_dolatkhah@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Dr.Majid Hajifaraji
Position
PhD(Clinical Nutrition), FNS MSc & PG Dipl., Research Associate Professor
Other areas of specialty/work
Street address
Faculty of Nutrition & Food Technology, 3, Baran, West Arghavan, Farahzadi Blvd., Shahrak Qods, Tehran, Iran
City
Tehran
Postal code
1981619573
Phone
+98 21223606612
Fax
+98 21 2237 6467
Email
m39faraji@yahoo.com; m.hajifaraji@nnftri.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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